Kornimate/medical-research-clean huggingface dataset:
a study of ct-388 in participants with obesity or overweight with at least one weight-related comorbidity

Conditions: Obesity; Overweight

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of ct-388 at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 75 years of age * body mass index (bmi) ≥30.0 kg/m2, or bmi ≥27.0 and \<30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease * at least one self-reported unsuccessful effort to lose body weight exclusion criteria: * prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., type 1, type 2, gestational), or a history of ketoacidosis or hyperosmolar state * self-reported body weight change of \>5 kg within 3 months before randomization * any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study * current or recent participation in an organized weight reduction program * current or recent use of any treatment that promotes weight loss or glucose metabolism * current or recent use of treatment that may cause weight gain * prior or planned surgical treatment for obesity * clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect gi motility * history of chronic pancreatitis or acute pancreatitis within 6 months before screening * have obesity induced by other endocrinologic disorders (e.g., cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity * history of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (note: prospective participants with depression or anxiety whose disease state, in the opinion of the investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion) * family or personal history of medullary thyroid carcinoma * serum calcitonin ≥ 20 ng/l * women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
tregocel® as a dietary supplement in mild knee osteoarthritis

Conditions: Mild Knee Osteoarthritis

Summary: this study is an assessment of the overall performance of participants with symptomatic mild knee oa taking tregocel® as a dietary supplement in addition to standard of care treatment.

tregocel® is a combination herbal product which as a dietary supplementation may help maintain proper performance of joints. although some studies have reported beneficial effects for individual components of tregocel®, there have been no clinical assessments of supplementation with tregocel® as a finished product. this study will involve collection of data on tregocel® supplementation in participants with symptomatic mild knee osteoarthritis (oa) who are already receiving standard pharmacological treatment.

Eligibility criteria:
inclusion criteria: * compliance with all study procedures * fulfilment of consent process * documented diagnosis of radiologically confirmed mild knee osteoarthritis with stable pain management (including patello-femoral joint, kellgren-lawrence classification ≤2 and clinical symptoms lasting more than 6 months prior to screening) * maximal pain score ≥30 on a 100 mm vas at screening and confirmed at baseline, with prn use of analgesics during run-in * completed patient diary during run-in * ambulant with ecog score \<2 exclusion criteria: * pregnancy or breastfeeding (women) * body mass index less than 18.5 kg/m\^2 or more than 35.0 kg/m\^2. * secondary knee oa * clinically apparent tense effusion of the target knee * valgus/varus knee/foot deformities, ligament laxity, or meniscal instability * changes in regular oa therapy during screening * chronic diseases which may require treatment with systemic steroids * progressive serious medical conditions * severe organ dysfunction * cardiac insufficiency * history of gastrointestinal ulcer or bleeding. * any significant medical conditions that may interfere with the study procedures, safety, compliance or overall participation in the study * allergies or intolerance to any of the dietary supplement ingredients

Keywords: dietary supplement arthritis joint complementary medicine
a clinical study to evaluate safety, tolerability and pharmacokinetics of oral hms5552 in healthy volunteers

Conditions: Type II Diabetes Mellitus

Summary: the objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of hms5552 following single ascending doses in healthy adult subjects.

this will be a randomized, double-blind and placebo-controlled safety study with single oral doses of hms5552 given to healthy volunteers. the primary objective is to characterize the safety profiles of hms5552 following single ascending doses (sad) in healthy adult subjects. the secondary objectives include: 1. to assess the pharmacokinetic profiles of hms5552 after single dosing 2. to assess the preliminary pharmacodynamic profiles of hms5552 each study subject will receive a single oral dose of hms5552. during each dosing, eight subjects will be allocated to receive hms5552 and two subjects will be allocated to receive placebo treatment. several doses of hms5552 will be tested. dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.

Eligibility criteria:
inclusion criteria: * female and male volunteers, 18 to 45 years of age * bmi: 18 to 24 kg/m2 * fasting plasma glucose: 3.9 to 6.1 mmol/l * glucose level at 2 hours following oral glucose tolerance test \<7.8 mmol/l * hba1c: 4 to 6.5% * normal supine blood pressure and normal ecg recordings exclusion criteria: * female with child-bearing potential * evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis. * intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day * clinically-relevant deviation from normal in the physical examination * subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
ultrasound-guided interscalene block:3ml ropi provide similar analgesia to 5ml and less diaphragmatic paralysis

Conditions: Diaphragmatic Paralysis

Summary: ropivacaine for ultrasound-guided interscalene block: 3ml provide similar analgesia to 5ml with less diaphragmatic paralysis in shoulder arthroscopy surgeries

ropivacaine for ultrasound-guided interscalene block: 3ml provide similar analgesia to 5ml with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume

Eligibility criteria:
inclusion criteria: * asa1-2 exclusion criteria: * asa3-4 anticoagulant
combined malonic and methylmalonic aciduria (cmamma): gene identification and outcome study

Conditions: Malonic Aciduria; Methylmalonic Acidemia

Summary: the investigators are interested in learning more about the changes found in the condition called "combined elevation of malonic and methylmalonic acid, or cmamma. " malonic, or ma and methylmalonic, or mma, are acids formed from the breakdown of protein under normal conditions. however, in the condition called cmamma there is an increase of these acids in the blood and urine, which is not normal. some people with high ma and mma in their blood and urine have a serious disease, starting as a baby or young child that includes heart disease and problems in learning. these people have changes in a special enzyme called malonyl coa decarboxylase (mcd). other people who have a high level of ma and mma do not have any obvious illness. the investigators are not sure why they have high levels of ma and mma and why they are not sick. the goal of this study is to learn more about why some people have a high level of ma and mma and to make sure there are no medical problems as a result of these high levels. the investigators also want to find out which gene and enzyme cause the high levels of ma and mma.


Eligibility criteria:
inclusion criteria: 1. elevated malonic and methylmalonic acid in blood and urine 2. any age 3. any sex 4. asymptomatic exclusion criteria: 1. defect in malonyl-coenzyme a decarboxylase (mcd) enzyme 2. history of metabolic acidosis, developmental delay and seizures

Keywords: malonic and methylmalonic aciduria malonyl-coenzyme a decarboxylase mlycd
study of the characteristics of pruritus in patients with frontal fibrosing alopecia or lichen planus pilaris

Conditions: Alopecia; Lichen Planus

Summary: the prevalence of pruritus has been studied in frontal fibrosis alopecia (ffa) and lichen planus pilaris (lpp), but there are no studies evaluating the characteristics of pruritus, the correlation between pruritus and disease activity, and its impact on quality of life. the knowledge of the characteristics of pruritus, of the link "disease activity - pruritus", and its impact on the quality of life could allow us to modify the management of the patient (modification or intensification of therapy, close monitoring...)


Eligibility criteria:
inclusion criteria: * major patient. * fibrosing frontal alopecia or lichen planus pilaris * presence of pruritus of the scalp : a positive response to the question "do you experience itchy scalp?" * the patient received an information note and did not object to the study exclusion criteria: * patients under 18 years of age. * other pathologies causing scalp pruritus (seborrheic dermatitis, contact dermatitis, lupus, quinquaud's decalcifying folliculitis, ectoparasitosis, scalp psoriasis, ringworm, red sclap syndrome, dermatomyositis, central centrifugal cicatricial alopecia (ccca)) * refusal to participate by the patient. * patient under legal protection (curatorship, guardianship, ...) * patient not covered by social security
impact of long term of benzodiazepine use on psychiatric manifestation

Conditions: Psychiatric Disorder; Benzodiazepine-Related Disorders

Summary: benzodiazepines are usually a secondary drug of abuse-used mainly to augment the high received from another drug or to offset the adverse effects of other drugs. few cases of addiction arise from legitimate use of benzodiazepines. pharmacologic dependence, a predictable and natural adaptation of a body system long accustomed to the presence of a drug, may occur in patients taking therapeutic doses of benzodiazepines. however, this dependence, which generally manifests itself in withdrawal symptoms upon the abrupt discontinuation of the medication, may be controlled and ended through dose tapering, medication switching, and/or medication augmentation. due to the chronic nature of anxiety, long-term low-dose benzodiazepine treatment may be necessary for some patients; this continuation of treatment should not be considered abuse or addiction. previous study reported that the results of the study are important in that they corroborate the mounting evidence that a range of neuropsychological functions are impaired as a result of long-term benzodiazepine use, and that these are likely to persist even following withdrawal. the findings highlight the residual neurocognitive compromise associated with long-term benzodiazepine therapy as well as the important clinical implications of these results.


Eligibility criteria:
inclusion criteria: * age from 18 years to 50 years * no history of neurological or medical illness exclusion criteria: * intelligence score more than 80

Keywords: psychiatric benzodiazepine
mind score for prolonged mechanical ventilation

Conditions: Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability

Summary: it was decided to develop a comprehensive disability score specifically designed for patients receiving prolonged mechanical ventilation (pmv); the collection of information included in the score should not impose any further intervention beyond what is routinely performed. so a new questionnaire was created (called the multi-independency dimensions (mind) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. each question was adapted to have a 5 item likert scale. the primary objective of the study will be to evaluate the psychometric performance of the mind score in terms of validity, reliability and sensitivity to change over time. the secondary objective will be to assess the inclusion of biological markers on the overall performance of the mind score

following recruitment all participants will be assessed by a medical doctor or respiratory therapist (trained on the study) who will fill out the mind questionnaire on admission and make sure the other scales/questionnaires are also completed. on the same day of the collection of mind, mrc score for quadriceps and biceps strength, sequential organ failure assessment (sofa) score, glasgow coma scale, hospital anxiety-depression scale (hads), euroqol-5d, gussago dependence nursing scale (gns) will be also gathered. after 1 day and 30 days the mind questionnaire will be also evaluated. index of adl-(katz index) will be evaluated on discharge as well as weaning rate and survival. sample size determination based on the method of rouquette a et al (1) we estimated a sample size of 200 patients to allow for the rasch modelling to be applied. statistical analysis assessment of construct validity: confirmation of the structure (e.g. multitrait analysis), clinical validity (comparison of disability score according to external clinical criteria) assessment of reliability: internal consistency reliability (using cronbach's alpha), test-retest reliability (using intraclass correlations) assessment of sensitivity to change over time: comparison of change in disability score according to change in external clinical criteria guidance for interpretation of disability score: estimation of thresholds for patients' classification 1-rouquette a, falissard b sample size requirements for the internal validation of psychiatric scales int j methods psychiatr res. 2011 dec;20(4):235-49. doi: 10.1002/mpr.352. epub 2011 oct 24.

Eligibility criteria:
inclusion criteria: * adult patients with prolonged mechanical ventilation and a diagnosis of acute lung injury, copd/chronic lung disease, neuromuscular disorders, post-operative, cardiovascular disorders, trauma, other. exclusion criteria: * expected length of stay \<48h, unable to achieve consent
a long-term trial investigating safety and efficacy of transcon hgh in children with growth hormone deficiency who have completed a prior transcon hgh clinical trial

Conditions: Growth Hormone Deficiency, Pediatric; Endocrine System Diseases; Hormone Deficiency; Pituitary Diseases

Summary: a multicenter, phase 3, long-term extension trial of transcon hgh administered once-weekly in children with growth hormone deficiency (ghd) who previously participated in a phase 3 transcon hgh trial. approximately 300 children (males and females) with ghd will be included. all study participants will receive transcon hgh. this is a global trial that will be conducted in, but not limited to, the united states, poland, bulgaria, ukraine, armenia, russia and australia.


Eligibility criteria:
inclusion criteria: 1. children who have completed a prior phase 3 transcon hgh trial 2. children who have not permanently discontinued study drug in the prior trial 3. written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the irb/hrec/iec exclusion criteria: 1. poorly-controlled diabetes mellitus (hba1c ≥ 8.0%) or diabetic complications 2. evidence of closed epiphyses, defined as bone age \> 14.0 years for females or \> 16.0 years for males 3. major medical conditions unless approved by medical expert 4. known hypersensitivity to the components of the trial medication 5. likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 6. pregnancy 7. any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule

Keywords: human growth hormone hgh ghd rhgh pediatric growth hormone deficiency long acting growth hormone somatropin prodrug growth failure growth hormone replacement therapy sustained release growth hormone growth hormone deficiency transcon gh
registry of complete responses to sunitinib in spanish patients with metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: observational, retrospective, multicentre study in spanish patients with metastatic renal cell carcinoma (mrcc) treated with sunitinib as a first-line treatment (treatment with previous cytokine therapy is accepted) according to clinical practice who obtained a complete response (cr) to treatment in one of these 2 situations: 1. complete response (cr) obtained exclusively with first-line sunitinib treatment (sunitinib cr). 2. response obtained after a period of time on treatment with sunitinib in which local treatment was also performed (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) to achieve the total macroscopic disappearance of the disease, according to the opinion of the physician responsible for the patient (cr + local treatment).


Eligibility criteria:
inclusion criteria: 1. patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 september 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. this response must have been reached through two possible strategies: a) systemic treatment with sunitinib alone. b) treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, sbrt (stereotactic body radiation therapy)). 2. the duration of cr must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. although the patient had progressed subsequently, he/she may be included in this registry. 3. patients from any risk group 4. tumours of any histology exclusion criteria: 1. patients treated with another drug other than sunitinib. 2. patients with no radiology reports proving cr. 3. patients with no record of the dose and regimen received with sunitinib. 4. patients who achieved complete remission after 30 september 2018.

Keywords: carcinoma, renal cell disease-free survival sunitinib protein kinase inhibitors angiogenesis inhibitors prognosis
assessment of inflammatory biomarkers expressed in a sjogren's population: effect of a topical steroid intervention

Conditions: Sjogren's Syndrome

Summary: the primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of sjogren's syndrome participants after treatment with maxidex.


Eligibility criteria:
inclusion criteria of sjorgren's population: inclusion criteria: * 17 years or older * logmar visual acuity of 0.6 or better * ocular inflammation associated with sjogren's syndrome exclusion criteria: * has had an adverse reaction to either topical of systemic steroids in the past * has diabetes (type 1 or 2) * has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of visit 1 * has worn contact lenses within one week prior to visit 1 * has received ocular prescription therapy in the last 30 days * has active ocular infections or inflammation not associated with sjogren's syndrome. * has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant

Keywords: ocular inflammation
palliative care during intraperitoneal chemotherapy in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: palliative care may help improve the quality of life of patients with ovarian cancer who are undergoing intraperitoneal chemotherapy. purpose: this clinical trial is studying palliative care in patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

objectives: * describe symptoms/concerns before, during, and after intraperitoneal (ip) chemotherapy and the impact of these symptoms/concerns on the quality of life (qol) of patients with ovarian cancer undergoing ip chemotherapy. (part i) * analyze care received and resource utilization of these patients, including length of hospitalization, icu admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters. (part i) * develop palliative care assessment measures and interventions that apply to ip chemotherapy. (part ii) * implement a palliative care intervention in a pilot of 6 patients. (part ii) * describe the impact of implementing palliative care interventions on resource utilization, improved qol and symptoms, and number of chemotherapy courses completed. (part ii) outline: this is a two-part study. * part i (retrospective portion): patients who have undergone intraperitoneal (ip) chemotherapy within the past 6-12 months undergo a retrospective interview and chart audit to identify their needs and experiences. * part i (prospective portion): patients are followed monthly for up to 6 months during ip chemotherapy to provide information about usual care and to identify needs and palliative care concerns. patients also complete a quality-of-life (qol) questionnaire (coh qol ovarian tool) and undergo a prospective interview. * part ii (intervention): patients undergo comprehensive palliative care assessment, a patient teaching session prior to the initiation of ip chemotherapy, and a palliative care intervention during ip chemotherapy. patients also complete a qol questionnaire and undergo an interview. patients are followed monthly for up to 6 months during ip chemotherapy.

Eligibility criteria:
disease characteristics: * diagnosis of ovarian cancer * under the care of the medical oncology department at the city of hope national medical center * undergoing intraperitoneal chemotherapy patient characteristics: * life expectancy \> 6 months * speaks english or spanish prior concurrent therapy: * see disease characteristics

Keywords: recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage i ovarian epithelial cancer stage i ovarian germ cell tumor stage ii ovarian epithelial cancer stage ii ovarian germ cell tumor stage iii ovarian epithelial cancer stage iii ovarian germ cell tumor stage iv ovarian epithelial cancer stage iv ovarian germ cell tumor